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N/A N=45 Randomized Double-blind Treatment

A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses

Astigmatism Bilateral

Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Ease of Insertion(Handling) — 9.1; 9.2 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Comfilcon A (test) (Device); Senofilcon C (control) (Device)
Age
Pediatric, Adult, Older Adult · 17+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Ease of Insertion(Handling)
8.8; 8.5
PRIMARY
Ease of Insertion (Handling)
8.9; 8.5
PRIMARY
Ease of Insertion(Handling)
8.8; 8.5
SECONDARY
Rotational Recovery After Lens Mislocation
26; 23; 23; 18
SECONDARY
Rotational Recovery After Lens Mislocation
26; 23; 23; 18

Summary

The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.

Eligibility Criteria

Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has had a self-reported oculo-visual examination in the last two years.
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
  • Is willing to wear contact lens in both eyes for the duration of the study;
  • Has a minimum astigmatism of - 0.75, determined by refraction;
  • Can be fit with the two study contact lens types in the powers available;
  • Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
  • Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
  • Has clear corneas and no active* ocular disease;

Exclusion Criteria

A person will be excluded from the study if he/she:

  • Is participating in any concurrent clinical trial;
  • Has any known active* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study measure;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
  • Has known sensitivity to fluorescein dye or products to be used in the study;
  • Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  • Is aphakic;
  • Has undergone refractive error surgery;
  • Has participated in the previous QUENA study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03684928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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